HalfLytely Bisacodyl Bowel Prep Kit

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Brand NameHalfLytely Bisacodyl Bowel Prep Kit
Generic Namebisacodyl, polyethylene glycol 3500, KCl, NaHCO3, NaCl
Marketed byBraintree Laboratories
NDA/BLA HolderBraintree
NDA/BLA NumberNDA 21-551/S-013
NDA/BLA Approval Date05/10/2004
Review ClassificationStandard
REMS Approval Date7/16/2010
Class REMSNo
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Boxed Warning?
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Communication Plan
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Elements to Assure Safe Use
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Approval Letters


REMS Document: from FDA Approved REMS

Approval Letters: from FDA Medication Guide Website

Approved Labeling: from FDA Medication Guide Website

Medication Guide: from FDA Medication Guide Website

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